ABOUT THE EVENT SERIES

The Annual Biosimilars Forum event series examines the actual challenges of biosimilar and nanotechnology formulated drug development for research management, leadership and support teams working in and for biosimilar drug development. The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling.

This year’s event was held in Budapest at the Event Hall of Acclesiors CRO, on 25 – 27 October, 2018 covered important issues and specific areas of debate facing clinical development teams specialized in bio- and nanosimilar development with a strong focus on statistical and regulatory perspectives. As in previous years, the program of the event was supported and complemented by leading experts from the fields of regulatory, academic and clinical research.

UPCOMING EVENT (Q4 of 2019):

Based on the success of our last years’ events, we have started to prepare our next, 4th Annual Biosimilars Forum, will be held in autumn of 2019 in Budapest. The detailed programme will be available soon here, until then we recommend you read more about our previous forums!

SPEAKERS AND LECTURERS (2018 OCT):

The 3rd Annual Biosimilars Forum was hosted in Budapest in the end of October (2018), clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on the most important issues and challenges of biosimilar research in lectures and informal discussions. Some internationally renowned expert speakers of the Forum:


Raj BAWA
President of Bawa Biotech LLC; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA


László ENDRÉNYI
Professor Emeritus from the University of Toronto, Canada; Former President of Canadian Society for Pharmaceutical Scientists, Canada


Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany


Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK


Andrea LASLOP
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria


Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA

Lecture examples from the 3rd Annual Biosimilars Forum (2018 OCT):

  PK short course

Uni- and multivariate Bioequivalence of PK parameters

Thomas JAKI: Professor of Statistics, Lancaster University, UK;
co-author: Philip PALLMANN: Deputy Director RDCS and Research Fellow, Cardiff University, UK

  PK short course

Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints

Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Germany

  Regulatory Keynote Presentation

The biosimilar concept revisited – is there a need for change?

Andrea LASLOP
European Regulatory Expert;
Unit Head, Austrian Medicines and Medical Devices Agency, Austria

  Regulatory

Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars

Ágnes GYURASICS
Unit Head at National Institute of Pharmacy and Nutrition, Hungary

  Scientific Keynote Presentation

Bioequivalence of highly variable drug products – an update

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Canada

  Case Study

How the increase of assay sensitivity influences the immunogenicity

How the increase of assay sensitivity influences the immunogenicity
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany

  Case Study

Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Hungary

  Seminar (Nanomedicine)

The Era of Biosimilars and Nanosimilars: Current Perspectives

Raj BAWA
President of Bawa Biotech LLC; Founding Director of American Society for Nanomedicine, USA

SCIENTIFIC PROGRAMME COMMITTEE

Ildikó ARADI 
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc.

Bernd JILMA 
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

Franz KÖNIG 
Associate Professor, Section for Medical Statistics, Medical Unversity of Vienna

Stephan LEHR 
Statistician, Austrian Medicines and Medical Devices Agency; President, Viennese Section of IBS

Júlia SINGER 
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics

Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis

TESTIMONIALS

  • Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.

    –Bernd JILMA | Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

  • I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!

    –Ildikó ARADI | Head of Clinical Development of Biologics, Gedeon Richter Plc.

  • These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …

    –László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto

  • The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.

    –Shein-Chung CHOW | Professor, Duke University School of Medicine

  • These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.

    –János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University

We had 3 very successful and professionally fruitful events in the previous years in a row, please read more about our former forums!

The summary page about our previous events is available in:

LEARN MORE ABOUT THE PREVIOUS EVENTS!

At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research.
Click on the button below and take a look at the professional lectures of our events, short video interviews with the key speakers, photo galleries and more.

SOME SPEAKERS FROM OUR PREVIOUS FORUMS

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada

Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna, Austria

Andrea LASLOP  
Unit Head, Austrian Medicines and Medical Devices Agency, Austria

Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Hungary